Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 71335-2117
- 11-digit product format
- 713352117
- Labeler code
- 71335
- Product ID
- 71335-2117_458d2586-8dba-4505-81c9-76719b5dcd2c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA211487
- Marketing category
- ANDA
- Marketing start
- 2018-11-08
- Substance
- ACETAMINOPHEN; HYDROCODONE BITARTRATE
- Active strength
- 325; 5 mg/1; mg/1
- Pharmacologic classes
- Opioid Agonist [EPC], Opioid Agonists [MoA]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 362O9ITL9D | ACETAMINOPHEN | 103-90-2 | ACETAMINOPHEN |
| NO70W886KK | HYDROCODONE BITARTRATE | 34195-34-1 | HYDROCODONE BITARTRATE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-2117-0 | 71335211700 | 10 TABLET in 1 BOTTLE (71335-2117-0) | 10 tablet | 2022-06-20 | No | No | Historical |
| 71335-2117-1 | 71335211701 | 30 TABLET in 1 BOTTLE (71335-2117-1) | 30 tablet | 2022-06-20 | No | No | Historical |
| 71335-2117-2 | 71335211702 | 120 TABLET in 1 BOTTLE (71335-2117-2) | 120 tablet | 2022-06-20 | No | No | Historical |
| 71335-2117-3 | 71335211703 | 20 TABLET in 1 BOTTLE (71335-2117-3) | 20 tablet | 2022-06-20 | No | No | Historical |
| 71335-2117-4 | 71335211704 | 60 TABLET in 1 BOTTLE (71335-2117-4) | 60 tablet | 2022-06-20 | No | No | Historical |
| 71335-2117-5 | 71335211705 | 90 TABLET in 1 BOTTLE (71335-2117-5) | 90 tablet | 2022-06-20 | No | No | Historical |
| 71335-2117-6 | 71335211706 | 50 TABLET in 1 BOTTLE (71335-2117-6) | 50 tablet | 2022-06-20 | No | No | Historical |
| 71335-2117-7 | 71335211707 | 40 TABLET in 1 BOTTLE (71335-2117-7) | 40 tablet | 2022-06-20 | No | No | Historical |
| 71335-2117-8 | 71335211708 | 15 TABLET in 1 BOTTLE (71335-2117-8) | 15 tablet | 2022-06-20 | No | No | Historical |
| 71335-2117-9 | 71335211709 | 84 TABLET in 1 BOTTLE (71335-2117-9) | 84 tablet | 2022-06-20 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| ® Tablets | Bryant Ranch Prepack | 2025-10-21 | HUMAN PRESCRIPTION DRUG LABEL | 102 |
| ® Tablets | Bryant Ranch Prepack | 2023-11-27 | HUMAN PRESCRIPTION DRUG LABEL | 101 |